EMA’s human medicines committee (CHMP) has confirmed its initial recommendation to not renew the conditional marketing authorisation for Blenrep (belantamab mafodotin) because recent data did not confirm its effectiveness; the benefits of Blenrep are therefore considered to no longer outweigh its risks.

Blenrep is a medicine for treating multiple myeloma (a cancer of the bone marrow). It was authorised for adults who had received at least four previous treatments and whose disease did not respond to certain other types of treatment and had worsened since the last treatment.

During a re-examination requested by the company that markets the medicine, the CHMP re-assessed the results from the DREAMM-3 study, which compared Blenrep with pomalidomide plus low-dose dexamethasone.

The study did not find that patients who received Blenrep lived longer without their disease getting worse when compared with patients who received pomalidomide plus dexamethasone. As confirming this progression-free survival was a requirement at the time of Blenrep’s initial authorisation, the Committee concluded that the data did not confirm the medicine’s benefits and recommended not renewing its authorisation.

During the re-examination, the CHMP consulted a scientific advisory group (SAG) comprising of experts in the treatment of cancer. These experts were of the view that the DREAMM-3 study did not confirm the effectiveness of Blenrep. However, the majority of SAG experts were also of the opinion that Blenrep could be a treatment option for some patients for whom other treatments were not suitable.

In reaching its final opinion, the CHMP considered the views of the SAG, the results of the DREAMM-3 study which failed to confirm the effectiveness of Blenrep, and the medicine’s safety profile. All these considerations informed the CHMP’s conclusion that the benefits of Blenrep no longer outweigh its risks and its recommendation not to renew the medicine’s conditional marketing authorisation.

EMA will now send the CHMP’s opinion to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.

Information for patients

• EMA has recommended not renewing the marketing authorisation for the cancer medicine Blenrep. Once this recommendation is confirmed by the European Commission, Blenrep will no longer be authorised in the EU. However, the company may still supply the medicine through compassionate use or named-patient programmes to patients already receiving Blenrep.
• Blenrep was approved to treat multiple myeloma. As data were limited at the time of authorisation, the medicine was approved on the condition that the company carried out a study to confirm its effectiveness.
• The DREAMM-3 study failed to show that patients treated with Blenrep lived longer without their disease getting worse compared with those treated with pomalidomide and low-dose dexamethasone, another authorised treatment for multiple myeloma.
• As the medicine's effectiveness could not be confirmed, EMA concluded that the benefits of Blenrep are considered to no longer outweigh its risks.
• If you are receiving Blenrep, you should speak to your doctor about this decision and what it means for you and your treatment.

Information for healthcare professionals

• EMA has recommended not to renew the conditional marketing authorisation for Blenrep, because recent data did not confirm its effectiveness; the benefits of Blenrep are therefore considered to no longer outweigh its risks.
• Once this recommendation is confirmed by the European Commission, Blenrep will no longer be authorised in the EU. However, the company may still supply the medicine through compassionate use or named-patient programmes to existing patients.
• Healthcare professionals should not start any new patients on Blenrep.
• Blenrep received a conditional marketing authorisation in August 2020; the marketing authorisation was subject to annual renewals based on the results of additional studies imposed on the marketing authorisation holder.
• The recent DREAMM-3 study failed to show that patients treated with Blenrep lived longer without disease progression than those treated with pomalidomide and low-dose dexamethasone.
• This phase 3, open-label, randomised (2:1) study compared Blenrep with pomalidomide and low-dose dexamethasone in 325 patients with relapsed/refractory multiple myeloma. The primary endpoint agreed as part of the specific obligation was superiority in investigator-assessed progression-free survival (PFS). The study found no statistically significant difference in PFS between the two groups (HR 1.03; 95% confidence interval: 0.72, 1.47).

More about the medicine

Blenrep was authorised in the EU on 25 August 2020 for the treatment of multiple myeloma (a cancer of the bone marrow). It is given to adults who have received at least four previous treatments and whose disease did not respond to treatment with at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody (types of cancer medicines), and whose cancer has worsened since receiving the last treatment.

Multiple myeloma is a rare cancer of a type of white blood cells called plasma cells. Normal plasma cells are found in the bone marrow and are an important part of the immune system. When plasma cells become cancerous, they no longer protect the body from infections and produce abnormal proteins that can cause problems affecting the kidneys, bones or blood.

Blenrep is a monoclonal antibody attached to a cytotoxic (cell-killing) molecule. It targets a protein called B-cell maturation antigen (BCMA), which is present on the surface of the multiple myeloma cells. By attaching to BCMA, the medicine releases the cytotoxic molecule into the cells to kill the multiple myeloma cells.

More about the procedure

The renewal of the marketing authorisation application for Blenrep was assessed by EMA’s Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted EMA’s initial opinion on 15 September 2023.

The company that markets Blenrep asked for re-examination of the CHMP’s opinion on 21 September 2023. After conducting the re-examination, the CHMP issued its final opinion on 14 December 2023.

EMA will now send the final CHMP opinion on the renewal application to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.

Published on: 17 January 2024